Regulatory Affairs Manager - CTA
Proclinical are recruiting for a Regulatory Affairs Manager - CTA to join a pharmaceutical organisation. This role is on a contract basis and is located in either Uxbridge or Cambridge.
- Accountable for preserving a working expertise of regulatory needs and regulations.
- Discuss alterations in regulatory information to product teams and senior management.
- Assist the director inflammation regulatory affairs when needed.
- Serve as a representative for the regulatory function at cross-functional team meetings.
- Engage with the international regulatory leads to guarantee optimal implementation of the approved regulatory method for development of medicinal products.
- Other duties may be assigned.
Key Skills and Requirements:
- Able to arrange the preparation of numerous multifaceted regulatory documentations for international clinical trials in cooperation with other functions.
- Know-how of the EU clinical trials guidelines would be ideal.
- Exhibited ability to handle, formulate and implement method.
- Works well in a team.
- A self-starter who is capable of taking personal ownership as well as takes the initiative.
- Educated to a degree level in a life science field with exhibited experience within regulatory affairs.
- Communication skills both verbally and in writing.
- Fluency in the English language.
- Experience with efficiently resolving issued with an analytical and assessment mindset.
- Works well independently with the capacity to plan and seek information.
- A high attention to detail.
- Comprehension of customers both internally and externally as well as efficiently relating to them.
- Business consciousness with the ability to present self in a professional manner.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.